HS Fiber Cerclage— 510(k) K220765

Substantially Equivalent

Riverpoint Medical, LLC

FDA 510(k) clearance K220765 for HS Fiber Cerclage, Substantially Equivalent on 2023-07-26. Applicant: Riverpoint Medical, LLC.

Clearance details

Applicant: Riverpoint Medical, LLC
Product code: Code JDQ
Advisory panel: Orthopedic
Date received: 2022-03-16
Decision date: 2023-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.